FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3190995
·
Received June 21, 2013
Report
- Report Number
- 3008642652-2013-01592
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 20, 2013
- Report Date
- June 21, 2013
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (FALSE ASYSTOLE DETECTION) WAS CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED A FALL-OFF TEST. THE CAUSE FOR THE FAILURE WAS ISOLATED TO THE ECG C AND D CABLE. THE GREEN (BELT DISCHG) WIRE WAS DRAWING LOW CURRENT. THE ROOT CAUSE FOR THE LOW CURRENT DRAW COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BELT. THE PT REC'D A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A ZOLL PT SERVICE REP (PSR) CALLED TO REPORT THAT A (B)(6) FEMALE PT'S ELECTRODE BELT WAS NOT WORKING. THE ELECTRODE BELT WAS DETECTING A FALSE ASYSTOLE. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283182 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |